Welcome to GeneProof website!

It is great to see you here. To see all contents of the website, please register or restore your access.
We believe you will come back gladly.

GeneProof Team

 

User account
Forgot your password?
Searching

GeneProof Hepatitis C Virus (HCV) PCR Kit

CE 1023 IVD On request

PRODUCT ADVANTAGES

 

DETECTS A BROAD SPECTRUM OF HCV GENOTYPES

  • The kit detects HCV genotypes 1 – 7

SINGLE TUBE READY-TO-USE MASTERMIX

  • Contains all components for PCR amplification
  • No additional PCR reagents pipetting necessary
  • Reduces the need for qualified laboratory staff
  • Ensures reproducibility of the results

INTERNAL RNA CONTROL

  • Controls the whole diagnostic process
  • RNA extraction, reverse transcription and PCR amplification
  • IC is included in the PCR Kit

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE IVD CERTIFIED DIAGNOSTIC TEST

 

Product on request. For more information contact your sales manager or [obfuscate_1_|114|89|99|94|115|63|95|92|103|101|111|106|102|104|102|45|91|102|102].

Order information

Product name Catalog no. Technology Packaging
GeneProof Hepatitis C Virus (HCV) PCR Kit HCV/PLUS/025 real-time PCR 25 reactions
GeneProof Hepatitis C Virus (HCV) PCR Kit HCV/PLUS/100 real-time PCR 100 reactions

EQA Panels

EQA results

GP_HCVplus_QCMD_2020_EN
pdf, [192.63 kB]
GP_HCV_Instand_03_21_EN
pdf, [1.02 MB]
GP_HCV_Instand_04_20_EN
pdf, [909.63 kB]
GP_HCV_QCMD_EN
pdf, [167.06 kB]
Choose all

Technical specification

Indication in vitro diagnostic medical device
Intended User For professional use in laboratories with trained staff
Technology real-time PCR
Target Analysis qualitative and quantitative 
Target Sequence conservative region of 5' UTR sequence
Analytical Specificity HCV genotype 1–8, 100 %
Analytical Sensitivity (LoD)

Reaches up to 7.87 IU/ml with the probability of 95% (on AcroMetrix
HCV High Control using automatic extraction MagCore NA Extractor)
Reaches up to 208.54 IU/ml with the probability of 95% (on AcroMetrix
HCV High Control using automatic extraction croBEE NA16 Nucleic Acid
Extraction System)
Reaches up to 213.965 IU/ml with the probability of 95% (on HCV NIBSC
14/150 using manual extraction GeneProof PathogenFree RNA Isolation
Kit)

   
 Linear Range  1010 - 25 IU/ml with precision of ± 0.5 log
Dynamic Range  1010 - 7.87 IU/ml
Reporting Units
IU/μl (1 IU = 5.62 cp)
Validated Specimen Plasma, serum
Storage -20 ± 5 °C  
Validated Extraction Methods

croBEE NA16 Nucleic Acid Extraction System
GeneProof PathogenFree RNA Isolation Kit

Instruments

croBEE Real-Time PCR System*
Applied Biosystems 7300 / 7500 Real-Time PCR System
AriaMx Real-Time PCR System
CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System
DT lite Real-Time PCR System
LightCycler® 2.0 / 480
LineGene 9600 / 9600 Plus
Rotor-Gene 3000 / 6000 / Q
SLAN® Real-Time PCR System

Required Detection Channels FAM, HEX
External Quality Assessment Regularly tested by QCMD and INSTAND e.V. External Quality Assessment panels - results available at www.geneproof.com
Regulatory Status CE1023 IVD for in vitro Diagnostic Use 

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.49 MB]
GP_HCV_Instruction for Use_EN
pdf, [367.94 kB]

Declaration of Conformity

GP_FQAS EC Certificate_EN
pdf, [48.26 kB]
GP_HCV_Declaration of Conformity_EN
pdf, [298 kB]

MSDS

GP_HCV_PCR_Kit_Safety Data Sheet_PCR Kit_EN
pdf, [140.74 kB]

PCR Template

GP_HCV_Mic
micassay, [13.09 kB]

Manual

croBEE Real-Time PCR System_EN
pdf, [5.9 MB]
Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
Files are available only for registered users.

News

GeneProof detect OMICRON variant

A new variant of the SARS-CoV-2 virus, known among others as OMICRON, is spreading around the world.…

Let's meet at MEDICA 2021 in Düsseldorf

Meet us at MEDICA 2021 World Forum for Medicine!